Data presented today at the International AIDS Conference in Melbourne and published simultaneously in the Lancet provides the first clear evidence for who wants PrEP—and how they use it outside of the United States.

While PrEP demand and demonstration projects have gathered steady momentum in the United States, the pace has been far slower in other parts of the world—including countries where some of the original trials happened. In the absence of evidence that people want and will use PrEP, there’s been plenty of debate about the viability of this strategy, particular in low- and middle-income settings.

The new data from the iPrEX Open Label Extension study (iPrEX OLE) are a welcome antidote to this skepticism. The study was open to iPrEx participants who remained HIV negative at the end of the blinded, randomized trial, as well as HIV-negative participants from two smaller safety studies. Participants were offered the chance to take daily oral tenofovir-based PrEP. Participants could also decline and remain enrolled, receiving the same counseling and care. The participants were gay men and other men who have sex with men and transgender women from Latin America, the US and South Africa. For much of the study, participants attended clinic visits every two months—less frequently than the monthly visits that were standard in the efficacy trials to date, including iPrEx.

There is much to learn from these data, and AVAC will be working with partners in the coming weeks to discuss the implications and findings in greater detail. For now, here are some key findings:

• Uptake of PrEP was higher among OLE participants than it has been in the general population of gay men, MSM and transgender women. This suggests that when people are informed—as these former trial participants were—of efficacy and safety of daily oral PrEP, they are more likely to use it. There’s a lot of work to be done to build awareness and demand in many countries—especially since the argument that “there’s low demand, so why roll it out?” is being used to justify a slow pace of oral PrEP roll out in many settings where it could reduce infections.

• PrEP works if you take it. This isn’t news but the study confirms it. In OLE, as with every other efficacy trial, people who had detectable drug in their blood—indicating that they had taken one or more PrEP doses—had less risk of HIV than those who did not. As with the original adherence/efficacy data, OLE calculated the risk at a given study visit, rather than in individuals over time. For example, the study is able to draw conclusions about the probability that someone with drug level “x” in their blood at a given study visit would test HIV positive at that visit. Higher drug levels means more protection. OLE also analyzed levels of protection based on levels corresponding to more-or-less daily dosing, compared with more infrequent dosing. Not surprisingly, more frequent dosing led to more protection. But even infrequent dosing reduced risk compared to people who weren’t taking PrEP at all. Overall, PrEP use was associated with a 50 percent reduction in risk of HIV compared to people in OLE who weren’t taking PrEP—and to HIV rates in participants in previous trials.

• People at higher risk of HIV were more likely to choose to take PrEP and more likely to take PrEP consistently over time. The study authors write, “Such preferential use of PrEP during times of greater risk is expected to increase the effect and cost effectiveness of PrEP services, and shows people’s capacity to recognize and respond appropriately to risks when given attractive options.” We couldn’t say it any better.

• Blood levels of tenofovir diphosphate (the active form of tenofovir-based PrEP) weren’t as high in transgender women, so protection also wasn’t as high. There is an urgent need to gather more data on how PrEP is used in transgender women, how tenofovir-based drugs interact with exogenous hormones, and how this strategy can be adapted for use by a population with soaring rates of HIV infection.

These are some basic top-line messages. Please subscribe to our Advocates’ Network and visit prepwatch.org for more in-depth information and analysis in the weeks to come.

Originally appeared on the Huffington Post.

Last week, the World Health Organization (WHO) issued new comprehensive guidelines for addressing HIV/AIDS in so-called “key populations” — the current global health lingo for often-marginalized populations that are heavily affected by the AIDS epidemic including gay men and other men who have sex with men, people in prison, people who inject drugs, sex workers and transgender people.

While the guidance had a number of new recommendations, the one that has received — and deserves — the most attention is the recommendation that gay men and other MSM be offered the option of oral PrEP (the use of a daily medication to reduce risk of HIV infection) as part of comprehensive HIV prevention services. It’s the first time that this new strategy has received an unqualified endorsement from WHO, and it is a most welcome development!

Unfortunately, it also highlights the work that global health agencies and funders have, to date, left undone to make the world a place where such a recommendation could be put into practice. It also risks limiting PrEP’s future impact. By inadvertently reinforcing perceptions that this option is just for gay men, the recommendation could slow efforts to deliver it to others, including millions of heterosexual women at risk for HIV.

These new WHO recommendations come two years after that agency issued guidance on PrEP demonstration projects in low-resource settings, and the US Food and Drug Administration (FDA) approved the use of daily Truvada as PrEP in the US.

The 2012 WHO guidance and FDA approval opened a new chapter in the global rollout of this effective prevention strategy, and they sent a critical message: PrEP is real, it works, and it should be made available now. The 2014 WHO recommendation on PrEP for MSM reinforces that message, and that is a good thing.

But PrEP is an option for many people, not only for gay men. (It isn’t for everybody, of course, but that is a decision to be made by individuals and their health providers.) Global health leaders should be working, now, to develop and fund programs to provide access for anyone who can benefit. Oral PrEP should be integrated into comprehensive, high-impact prevention programs for all people at risk internationally, with particular attention to key populations but also for young women and married women who continue to bear the brunt of the epidemic.

WHO needs to quickly issue guidance on PrEP for all of the populations that can benefit. The data are strong enough to warrant this move, as the US Centers for Disease Control and Prevention recently showed with its guidance that recommended that doctors consider oral PrEP for anyone at high risk of HIV infection. State and local health agencies, including in New York State, are currently conducting demonstration studies to figure out how best to get PrEP to those who need it.

Public health history tells us that a broad recommendation can actually help ensure that specific populations get access. When the hepatitis B vaccine was introduced in 1986, it was recommended only for specific populations, which ended up stigmatized the intervention. It wasn’t until it was repositioned as being a health tool for the general population that it took off.

This lesson should be borne in mind, particularly in light of the homophobic climates in many African countries with high rates of new infections in MSM, women and youth. If PrEP is viewed mainly as an option for MSM, country authorities could be resistant to providing access for anyone.

The scientific evidence of PrEP is as strong in other populations, including heterosexual women and men, and people who inject drugs. Clinical trials in multiple countries have shown that people who consistently take PrEP with oral TDF alone or in combination with emtricitabine (FTC), also known as Truvada, can reduce their risk of becoming HIV-infected by 90 percent or more.

Here in the United States, PrEP is gaining momentum, as are efforts to begin to deliver PrEP to all of the populations that can benefit.. And while gay men have been the most vocal users of PrEP so far, others are beginning to benefit. The poignant accounts by PrEP users and providers at myprepexperience.blogspot.com and just this week on the cover story of New York magazine offer hope that this new strategy will save and improve many lives, just as researchers and advocates have long hoped.

If the rest of the world follows America’s lead, PrEP could become an important global health success story. It is already being rolled out faster than earlier public health advances, from vaccines to tampons, oral contraceptive pills and the female condom — many of which took decades to get into the field. To realize PrEP’s potential, several specific things need to happen now.

In addition to expanded WHO guidance, Gilead Sciences Inc., the maker of Truvada, needs to move swiftly to secure regulatory approval in countries where PrEP is most needed. This starts with the countries that hosted clinical trials, where, tragically, PrEP is now out of reach. In two of those countries, South Africa and Thailand, Gilead recently filed for approval. This is an important and welcome step but the process needs to happen much faster and in more places. That requires both more aggressive efforts by Gilead and the willingness of national regulatory authorities to quickly review and approve the company’s applications.

Global health programs, including PEPFAR and the Global Fund, need to help countries design PrEP programs that meet the needs of their populations. A key part of this process is to launch large-scale demonstration studies in a wide range of countries and populations. Those studies can help planners understand how best to target PrEP to the people who need it most, and how to address key challenges like ensuring that people adhere to their daily medications. But so far, few of these studies outside the US have been launched or even planned.

Finally, global funders need to put substantial resources into well-planned PrEP programs. In particular, PEPFAR and the Global Fund should make sure that PrEP is not squeezed out by other funding priorities. National health authorities, who are increasingly and importantly taking ownership of their HIV prevention funding, also need to ensure a place for this intervention.

PrEP is not the perfect or only solution to the global AIDS epidemic — in fact, there is not, and never will be, such a silver bullet. We need integrated and sustained combination prevention and treatment programs. And oral PrEP as an option for all people at risk must be part of that. For the millions of people who stand to benefit from oral PrEP, let’s treat it like the advance and opportunity that it is.

This latest issue of Px Wire comes out on the eve of the International AIDS Conference in Melbourne, Australia—and we begin with “AVAC’s Take” on key messages and commitments to look for at and after the meeting. The bottom line: turn talk into action.

 This means building on the recent UNAIDS definition of what ending AIDS means and when it should happen, and it means getting specific about how to turn guidelines into public health programs for impact.

Click here to download.

As Px Wire went to press, the World Health Organization launched new comprehensive guidance for HIV prevention and treatment for key populations. This includes a strong recommendation for offering oral PrEP in programs for gay men and other men who have sex with men (MSM). This development drew headlines and has the potential to expand access to strategic prevention for individuals who need it most. But as we note in our “Data Dispatch”, there are still only two demonstration projects ongoing in Africa—one of the geographies where gay men and other MSM have high rates of HIV—usually in the context of low levels of services and human rights protections. Without a clear plan for a suite of projects that answer key questions about PrEP in MSM as well as other populations who can benefit from PrEP, the new WHO guidance will not have the impact it should.

Px Wire also provides an update on the proposed ECHO trial, which seeks to measure the impact of different family planning methods on women’s risk of HIV. Originally set to test four contraceptive methods, the most recent trial protocol has just three arms—a change that reflects challenges fundraising for this research.

Our centerspread, features our redesigned website—including searchable databases, an infographics galley and our new blog, P-Values.

The guidelines, the first national guidelines for PrEP use, provide instructions for health providers about providing daily TDF/FTC as PrEP for individuals at “substantial risk for HIV infection”; visit PrEP Watch to learn more about the guidelines, download materials and more.

And a group of 164 leading HIV/AIDS and health organizations today reiterated their strong support for oral PrEP as an important HIV prevention strategy for men and women at risk of HIV infection. The diverse group of advocates, researchers and service providers hailed new HIV PrEP guidelines from the US Centers for Disease Control and Prevention (CDC) as a science-driven, public health approach to what remains a major health crisis in the United States.

View the document here.